At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 945 enrolled
Drug / intervention
Nivolumab +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
In Brief
A Phase 3 clinical trial evaluating Nivolumab, Ipilimumab, and 2 other interventions for Unresectable or Metastatic Melanoma. Completed, enrolled 945 participants across 150 sites in 22 countries.
Detailed Summary
The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUnresectable or Metastatic Melanoma
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartJun 2013
Primary CompletionAug 2016
Study CompletionApr 2024
TodayJul 2026
First PostedMay 1, 2013
Enrollment StartJun 11, 2013
Primary CompletionAug 1, 2016
Study CompletionApr 19, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 13.2 years ago
Interventions
Nivolumabbiological
Ipilimumabbiological
Placebo for Nivolumabbiological
Placebo for Ipilimumabbiological